Improving Sleep With the Far-infrared Emitting Pyjamas

NCT ID: NCT04890002

Last Updated: 2023-09-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-15
• Study Completion Date: 2022-03-31

Brief Summary

The aim of this study is to explore the effects of a far-infrared emitting pyjamas on improving sleep in adults with poor sleep.

Detailed Description

Objectives: To explore the effects of a far-infrared emitting pyjamas on improving sleep in adults with poor sleep.

Hypothesis: Subjects who wear the far-infrared emitting pyjamas (FIR pyjamas) will have greater improvement in sleep quality than the subjects in sham pyjamas control group (sham-pyjamas) at 2, 4 and 6 weeks.

Design and subjects: A pilot randomized sham-controlled trial. Subjects with subjective sleep complaints will be recruited from the community. 40 subjects will be randomized to far-infrared emitting pyjamas and sham-pyjamas groups in a 1: 1 ratio. Study instrument: Pittsburgh Sleep Quality Index (PSQI) will be used as an overall evaluation of sleep quality.

Interventions: Subjects in the FIR pyjamas group will received pyjamas with far-infrared emitting features and will wear it every night for 6 weeks; subjects in the sham-pyjamas group will receive pyjamas in identical appearance without far-infrared emitting features.

Outcome measures: The primary outcome measure is the PSQI score. Other measures include insomnia severity index (ISI), sleep parameters derived from 7-day sleep diary, Hospital Anxiety and Depression Scale (HADS), Epworth Sleepiness Scale (ESS) and Satisfaction With Life Scale (SWLS) at 2, 4 and 6 weeks. Acceptability of the far-infrared emitting pyjamas will also be evaluated.

Data Analysis: Differences in the questionnaire scores, subjective sleep parameters will be examined using a mixed-effects model. Clinical significance of sleep improvement between two groups will be compared with chi-squared test.

Conditions

Sleep Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Far-infrared emitting pyjamas (FIR pyjamas) group

Subjects in this group will be provided the Far-infrared emitting pyjamas. The FIR pyjamas was fabricated by using two textile materials, pure cotton fibres and the proposed man-made FIR fibres with the far-infrared emitting function.

Group Type: EXPERIMENTAL

Far-infrared emitting pyjamas

Intervention Type: DEVICE

Clothing made in far infrared (FIR) - based textiles could be a sustainable way for alleviating sleep problems with many advantages. Firstly, the proposed far infrared textiles are made of man-made profiled fibers without the addition of chemicals such as ceramic additives or other related coatings.

Sham-pyjamas Group

To control the placebo effect in the FIR pyjamas group, participants in this group will receive pyjamas with identical physical appearance which are produced using the same fabrication process as the pyjamas received in FIR pyjamas group. The sham-pyjamas are made of pure cotton fibres and man-made fibres without the far-infrared emitting function. The participants will be asked to wear the sham-pyjamas daily at night for 6 consecutive weeks.

Group Type: SHAM_COMPARATOR

Sham-pyjamas

Intervention Type: DEVICE

The sham-pyjamas are made of pure cotton fibres and man-made fibres without the far-infrared emitting function.

Interventions

Far-infrared emitting pyjamas

Clothing made in far infrared (FIR) - based textiles could be a sustainable way for alleviating sleep problems with many advantages. Firstly, the proposed far infrared textiles are made of man-made profiled fibers without the addition of chemicals such as ceramic additives or other related coatings.

Intervention Type: DEVICE

Sham-pyjamas

The sham-pyjamas are made of pure cotton fibres and man-made fibres without the far-infrared emitting function.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Chinese Hong Kong residents who are able to read Chinese;
• Aged 18 - 65 years;
• Subjective sleep complaints of having difficulties in falling asleep, difficulties in staying asleep, or early morning awakening with consequences for daily life for at least 3 months.
• Pittsburgh Sleep Quality Index total score of at least 5 indicating sleep disturbance with 89.6% sensitivity and 86.5% specificity; and
• Willing to give informed consent and comply with the trial protocol.

Exclusion Criteria

• Currently receiving psychotherapy or participating in other clinical trials for insomnia;
• Pregnancy;
• Shift workers;
• At significant suicidal risk as rated by the Hamilton Depression Rating Scale item on suicide (score ≥ 3);
• No comorbid sleep disorders primarily requiring other treatment, such as sleep apnea or narcolepsy; and
• Taking herbal remedies, over-the-counter medication, or psychotropic drugs that target insomnia within the 2 weeks prior to baseline.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hong Kong Polytechnic University

OTHER

Sponsor Role: lead

Responsible Party

YEUNG Wing Fai

Dr

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wing Fai YEUNG, Dortor

Role: PRINCIPAL_INVESTIGATOR

Hong Kong Polytechnic University

Locations

Wing Fai YEUNG

Hong Kong, , Hong Kong

Countries

Hong Kong

Other Identifiers

SFEP

Identifier Type: -

Identifier Source: org_study_id